This invention relates generally to devices and methods to help dispense fluids, typically flowable biocompatible materials such as hemostatic agents, adhesives, sealants, or adhesion prevention agents, onto specific sites in the human body for a medical reason. For example, during a laparoscopic procedure a surgeon makes at least one small incision in the patient's body near the area of interest. A cannula or trocar may be inserted into the incision for access. Various surgical instruments are introduced into the patient's body through the trocar(s) as needed. Particularly troublesome is the case of dispensing fluids such as hemostatic agents to a target anatomical site deep inside the body cavity, as the site may be accessible only through this narrow trocar. Many times, the pathway to the target anatomical site is narrow and torturous, not a straight line. Therefore, to reach the target anatomical site the dispensing or delivery tube needs to have an adequate length, be bent at the appropriate angle, and have sufficient rigidity to maintain this appropriate angle when pushed against tissue through the torturous space.
SURGIFLO® Hemostatic Matrix Kit by ETHICON, Inc., a Johnson & Johnson Company, is a medical or surgical kit containing an applicator device for hemostats and human thrombin. Specifically, the kit contains a pre-filled, flowable hemostat in a syringe and applicator tips. Before delivering the hemostatic agent, an applicator device tip, or delivery tube, is secured to the syringe via a Luer-lock connection. The flowable hemostat is applied to a target anatomical area by positioning the free end of the applicator tip near a target anatomical site and then expelling an amount of the flowable hemostat. The surgical or hemostatic applicator is supplied with two applicator tips for precise placement of the flowable. This gives surgeons an option of choosing between a flexible and malleable applicator tip that has “memory” to ensure it stays at the optimum angle for easier access and exact product placement, and a non-malleable tip that can be cut with nursing dressing scissors to a desired length for providing the required penetration depth. The flexible and malleable tube is shaped or formed, typically by manual bending, into a desired configuration.
While the non-malleable tip, which is a straight plastic tube, can be trimmed to a desired length for application, it is not conformable to hold an angle. The flexible and malleable tube, which contains an embedded malleable metal wire, can achieve and maintain angle(s) and can be used for tough to reach sites. The flexible and malleable dispensing or delivery tube, however, is tough to trim due to its embedded metal wire and has the potential to lose its shape when pushed against tissue, which can impact accurate delivery of the material at the desired location. If more rigid wire is used, it would be more difficult for the surgeon to trim the tube, and there would be the potential to damage the surrounding tissue when forcefully advancing the dispenser.
Accordingly, there is a need for a dispensing or delivery tube on an applicator device that is formable to a desired angle at the right distance and is easily cut to the desired length. Importantly, it should maintain its form when pushed against tissue in a narrow and torturous space and not damage the tissue. Its form should also be maintained especially when fluids with high viscosity are delivered through the delivery tube.